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Last Updated: May 6, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207322

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NDA 207322 describes POLYMYXIN B SULFATE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Asi, West-ward Pharms Int, Xellia Pharms Aps, Xgen Pharms, and Paddock Llc, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the POLYMYXIN B SULFATE profile page.

The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.
Summary for 207322
Tradename:POLYMYXIN B SULFATE
Applicant:Gland Pharma Ltd
Ingredient:polymyxin b sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207322
Medical Subject Heading (MeSH) Categories for 207322
Suppliers and Packaging for NDA: 207322
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 207322 ANDA Gland Pharma Limited 68083-174 68083-174-10 10 VIAL in 1 CARTON (68083-174-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01)
POLYMYXIN B SULFATE polymyxin b sulfate INJECTABLE;INJECTION 207322 ANDA Athenex Pharmaceutical Division, LLC. 70860-103 70860-103-10 10 VIAL in 1 CARTON (70860-103-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70860-103-41)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500,000 UNITS BASE/VIAL
Approval Date:Apr 14, 2016TE:APRLD:No

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